{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-09-08", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "HOSPITAL", "report_to_fda": "", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "", "manufacturer_contact_address_1": "", "manufacturer_contact_pcity": "", "event_type": "Injury", "report_number": "2955842-2015-00460", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20150320", "manufacturer_address_2": "", "pma_pmn_number": "", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "OTHER", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "Consumer" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20150320", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "189392", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20150320", "brand_name": "DA VINCI SURGICAL SYSTEM", "generic_name": "ENDOSCOPIC INSTRUMENT CONTROL SYSTEM", "manufacturer_d_name": "INTUITIVE SURGICAL,INC.", "manufacturer_d_address_1": "", "manufacturer_d_address_2": "", "manufacturer_d_city": "SUNNYVALE", "manufacturer_d_state": "CA", "manufacturer_d_zip_code": "", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "", "manufacturer_d_postal_code": "", "device_operator": "HEALTH PROFESSIONAL", "model_number": "", "catalog_number": "", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "NAY", "device_age_text": "", "device_evaluated_by_manufacturer": "", "combination_product_flag": "N", "udi_di": "", "udi_public": "", "openfda": { "device_name": "System, Surgical, Computer Controlled Instrument", "medical_specialty_description": "Gastroenterology, Urology", "regulation_number": "876.1500", "device_class": "2" } } ], "product_problems": [ "Insufficient Device Problem Information" ], "reporter_state_code": "NY", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "", "date_changed": "20250812", "health_professional": "", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "", "patient": [ { "patient_sequence_number": "1", "date_received": "20150320", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Incontinence", "Laceration(s)", "Disability" ] } ], "distributor_city": "", "date_report": "20150218", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "4620539", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20150218", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "5767449", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "ON (B)(4) 2015, ISI RECEIVED VOLUNTARY REPORT MW5038187 WITH THE FOLLOWING EVENT DESCRIPTION: I UNDERWENT ROBOTIC PROSTATE SURGERY AT (B)(6) WITH (B)(6) ON (B)(6) 2010. OPERATING NOTES SHOWED PERFECT RESULTS. I LATER DISCOVERED USING OUTSIDE UROLOGIST, THAT MY URINARY SPHINCTER HAD BEEN CUT FROM 2 TO 8 O'CLOCK, AND WAS AN OBVIOUS DEFECT WITHOUT ANY HOPE OF RECOVERY. I SUPPLIED (B)(6) WITH THE FINDINGS AND THE UROLOGIST REPORT, WHICH HE RUDELY DISREGARDS AND FAILED TO ACKNOWLEDGE ANY RESPONSIBILITY OR ACCOUNTABILITY. I ASKED HOW THIS OP NOTES SHOWED NO TRACE OF ANY ISSUES, TO WHICH HE MADE DEFLECTIVE STATEMENTS. HIS ACTIONS REFLECT THAT OF GUILT AND COVERING UP ADVERSE EVENTS. I APPROACHED THE HOSP WITH THE SAME RESULTS AS THEY POINTED OUT THAT THE OPERATING NOTES SHOWED NO ISSUES. I AM PROOF THAT THERE WERE ADVERSE RESULTS, BEING DESCRIBED AS UNIVERSALLY INCONTINENT AND IMPOTENT DUE TO ROBOTIC SURGERY. (B)(6) HAS CHOSEN TO COVER UP THE NEGATIVE OUTCOME." }, { "mdr_text_key": "13102020", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "BASED ON THE INFORMATION PROVIDED, ISI HAS NOT DETERMINED THE ROOT CAUSE FOR THE POST-OPERATIVE COMPLICATIONS EXPERIENCED BY THE PATIENT. THERE IS NO ALLEGATION THAT A MALFUNCTION OF THE DA VINCI SYSTEM, AN INSTRUMENT, OR AN ACCESSORY OCCURRED. ISI HAS ATTEMPTED TO CONTACT THE PATIENT TO OBTAIN ADDITIONAL INFORMATION CONCERNING THE REPORTED EVENT; HOWEVER, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED AS OF THE DATE OF THIS REPORT. THE HOSPITAL NAME, SURGEON NAME, AND SURGERY DATE ARE UNKNOWN. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT CLAIMED THAT HIS URINARY SPHINCTER WAS CUT WHILE UNDERGOING A DA VINCI PROSTATECTOMY PROCEDURE. HE ALSO CLAIMED THAT HE HAS SUFFERED FROM BEING INCONTINENT AND IMPOTENT DUE TO UNDERGOING ROBOTIC SURGERY. HOWEVER, AT THIS TIME, THE CAUSES OF THE PATIENT'S OPERATIVE COMPLICATIONS ARE UNKNOWN." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" } ] }